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Around the nation: FDA sued for removing weight-loss drug from its shortages list


FDA is reconsidering its decision to remove Eli Lilly’s diabetes and weight-loss drug, tirezepatide, from an official list of shortages following a lawsuit from a compounding group, in today's bite-sized hospital and health industry news from California, Georgia, and Maryland. 

  • California: Last week, Gov. Gavin Newsom (D) signed a bill into law that will ban the sale of tampons and other menstrual products with certain levels of perfluoroalkyl and polyfluoroalkyl substances (PFAS), or forever chemicals. According to CDC, exposure to PFAS has been linked to kidney and testicular cancers, cholesterol increases, changes in liver function and hypertension, and preeclampsia during pregnancy. Under the law, the manufacture and sale of menstrual products that contain intentionally added PFAS will be prohibited by 2025. If PFAS have been unintentionally added, manufacturers will have to keep the chemicals below a level determined by the Department of Toxic Substances Control by 2027. Organizations that violate the law could also face fines. Assembly member Diane Papan (D), who authored the bill, called the legislation a "bright step forward for women's health." (Fry, Los Angeles Times, 9/30)
  • Georgia: According to an early CDC study, this year's flu vaccine may not be as effective as last year's vaccine. Based on vaccinated patients in South America, CDC estimated that this year's vaccine was 34.5% effective against hospitalization among high-risk groups, such as children, individuals with preexisting conditions, and older adults. In comparison, the estimated vaccine effectiveness against hospitalization was 51.9% last year. According to CBS News, the drop in effectiveness for this year's vaccine may be due to fewer cases from the "A(H1N1)pdm09" flu strain. Flu vaccines have typically performed better against H1N1 than H3N2 flu strains, but there were more detections of the H3N2 subtype in South America this year. According to the study's authors, "health authorities might anticipate similar levels of protection" in the Northern Hemisphere if it sees similar patterns of viral flu strains. "Overall, flu vaccination reduced the risk of hospitalization by about one-third, which would have a significant impact on disease burden," said David Daigle, a CDC spokesperson. "Receiving a flu vaccine can offer significant protection against severe outcomes." (Tin, CBS News, 10/3; Benadjaoud/Kekatos, ABC News, 10/3)
  • Maryland: Earlier this month, FDA announced that Eli Lilly had determined its manufacturing capacity can meet "present and projected" demand for tirzepatide following a sustained shortage. Therefore, the agency removed the drug from its official list of shortages. This decision means that compounding pharmacies are no longer allowed to fill prescriptions for compounded versions of tirzepatide more than 60 days after the announcement, which was made Oct. 2. In response, the Outsourcing Facilities Association sued FDA, saying that its decision to remove tirzepatide from the shortages list was "reckless and arbitrary." In its lawsuit, OFA argued that tirzepatide is still in shortage and that FDA's decision to remove it from the shortages list was "unlawful" since the agency failed to follow rule-making procedure and provide proper notice of its plans. On Friday, FDA said it would reconsider the decision to remove tirzepatide from its shortages list. The agency also said that it would not pursue any regulatory action against compounding pharmacies that make copies of the drug. In a filing, FDA said it wishes "to reevaluate the challenged decision" and has asked the plaintiffs to "submit additional information regarding tirzepatide's availability" as it reconsiders the decision. (Silverman, STAT+ [subscription required], 10/8; Palmer, STAT+ [subscription required], 10/11; Pierson, Reuters, 10/11)

Weight management and obesity care

Healthcare's approach to weight management and obesity care is rapidly evolving. To meet the present moment, stakeholders need to understand the landscape, manage new innovations, and prepare for care transformation.


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